Genetrace

The United States Food and Drug Administration (FDA or the Agency) has learned that your firm, Genetrace, has offered for sale in the United States a human immunodeficiency virus (HIV) serological diagnostic dried blood spot (DBS) card self-collection kit (hereinafter, your “HIV DBS card self-collection kit”) without marketing authorization, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under section 201(h)(1) of the FD&C Act, 21 U.S.C. 321(h)(1), your HIV DBS card self-collection kit is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

FDA has reviewed your company’s website at https://www.genetrace.com (last visited January 2026). Based on our review, your firm has offered its HIV DBS card self-collection kit for delivery to individuals and has intended for these individuals to use the kit to self-collect DBS samples and ship those samples to laboratories for HIV testing. FDA has determined that your HIV DBS card self-collection kit is adulterated under section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. 351(f)(1)(B) because it does not have an approved premarket approval application (PMA) in effect pursuant to section 515(a) of the FD&C Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the FD&C Act, 21 U.S.C. 360j(g). Your HIV DBS card self-collection kit is also misbranded under section 502(o) the FD&C Act, 21 U.S.C. 352(o), because notification of the intent to introduce the device into commercial distribution has not been provided to the agency, as required by section 510(k) of the FD&C Act, 21 U.S.C. 360(k).

FDA has not authorized your firm’s HIV DBS card self-collection kit for any use, including for use in HIV serological diagnostic testing.

In a letter dated March 31, 2025, FDA informed you that you appeared to be offering for sale and distributing your HIV serological diagnostic self-collection kits in a manner that may violate the FD&C Act. However, as noted above, your firm’s HIV DBS card self-collection kit has not received FDA marketing authorization for any use and to date, your firm has not submitted any premarket submission to FDA seeking authorization to market this kit.

Without appropriate testing, data review, and marketing authorization, there is a lack of assurance of the safety and effectiveness of your HIV DBS card self-collection kit. Self-collection raises several issues of importance, including, for example, whether the user can safely and properly collect the specimen, if the sample has been properly shipped, and if there is adequate stability of the specimen given the time lapse between collection and testing and the potential impact of shipping conditions. We also note that there is an FDA-approved over-the-counter HIV test that can help meet the needs of individuals who wish to test themselves at home or who are unable to access other testing options.

The violations cited in this letter are not meant to be an all-inclusive list of violations that may exist in connection with your products. FDA requests that your firm immediately cease any activities that result in the misbranding or adulteration of your HIV DBS card self-collection kit. Your firm should take prompt action to address the violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration in your response to this letter.

Within fifteen working days of receipt of this letter, please notify FDA in writing of the specific steps that you have taken to correct any violations. Your response should include an explanation of each step being taken to prevent the recurrence of violations as well as related documentation. If you cannot complete all corrective actions within fifteen working days, state the reason for the delay and the date by which you will complete the correction.

Send your electronic response and any questions regarding this letter to CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov.